Heart ArrestPhase 2/3VAM-IHCANCT03640949
Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest
A Phase 2/3 study testing Vasopressin, Arginine, Methylprednisolone and NaCl in people with Heart Arrest, run by Lars Wiuff Andersen at 10 sites in Denmark.
Trial summary
This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. There will be ten enrolling sites in Denmark. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Vasopressin, Arginine, Methylprednisolone and NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 501 participants
- Where
- 10 sitesDenmark
- Study dates
- 17 Sep 2018to 21 Jan 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation
Who cannot join
- Clearly documented "do-not-resuscitate" order prior to the cardiac arrest
- Prior enrollment in the trial
- Invasive mechanical circulatory support at the time of the cardiac arrest
- Known or suspected pregnancy at the time of the cardiac arrest
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Denmark10 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Copenhagen University Hospital - Rigshospitalet
Copenhagen
Copenhagen University Hospital - Gentofte
Hellerup
Copenhagen University Hospital - Herlev
Herlev
Horsens Regional Hospital
Horsens
Zealand University Hospital - Køge
Køge
Odense University Hospital
Odense
Randers Regional Hospital
Randers
Viborg Regional Hospital
Viborg
About this study
Official title: Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. There will be ten enrolling sites in Denmark. 492 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
- Conditions
- Heart Arrest
- Being tested
- Vasopressin, Arginine, Methylprednisolone, NaCl
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressin, ArginineDrug
20 IE of vasopressin per dose for a maximum of four doses (80 IU)
40 mg methylprednisolone once
NaClDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin and methylprednisolone | Experimental | The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Receives: Drug: Vasopressin, Arginine; Drug: Methylprednisolone |
| Placebo | Placebo comparator | The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Return of Spontaneous Circulation
Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes
Measured: During the cardiac arrest, an average of 20 minutes
Secondary outcomes (2)
Number of Participants That Survived 30 Days
Measured: At 30 days
Number of Participants With a Favorable Neurological Outcome at 30 Days
A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start17 Sep 2018
- Primary completion21 Jan 2021
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Wiuff Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Lars Wiuff Andersen, Aarhus University Hospital
- Investigators
- Lars W Andersen, MD, MPH, PhD, DMSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640949
- Sponsor's protocol ID
- 00001
- Other IDs
- 2017-004773-13, 2017
- Acronym
- VAM-IHCA
- Status last verified
- Feb 2022
- First submitted
- 19 Aug 2018
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. Data will be completely anonymized according to Danish law. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. There will be no predetermined end date for the data sharing.
Publications
Andersen LW, Isbye D, Kjaergaard J, Kristensen CM, Darling S, Zwisler ST, Fisker S, Schmidt JC, Kirkegaard H, Grejs AM, Rossau JRG, Larsen JM, Rasmussen BS, Riddersholm S, Iversen K, Schultz M, Nielsen JL, Lofgren B, Lauridsen KG, Solling C, Paelestik K, Kjaergaard AG, Due-Rasmussen D, Folke F, Charlot MG, Jepsen RMHG, Wiberg S, Donnino M, Kurth T, Hoybye M, Sindberg B, Holmberg MJ, Granfeldt A. Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Oct 26;326(16):1586-1594. doi: 10.1001/jama.2021.16628.
PubMed 34587236Andersen LW, Sindberg B, Holmberg M, Isbye D, Kjaergaard J, Zwisler ST, Darling S, Larsen JM, Rasmussen BS, Lofgren B, Lauridsen KG, Paelestik KB, Solling C, Kjaergaard AG, Due-Rasmussen D, Folke F, Charlot MG, Iversen K, Schultz M, Wiberg S, Jepsen RMHG, Kurth T, Donnino M, Kirkegaard H, Granfeldt A. Vasopressin and methylprednisolone for in-hospital cardiac arrest - Protocol for a randomized, double-blind, placebo-controlled trial. Resusc Plus. 2021 Jan 30;5:100081. doi: 10.1016/j.resplu.2021.100081. eCollection 2021 Mar.
PubMed 34223347
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03640949
- Acronym / sponsor ID
- VAM-IHCA / 00001
- Conditions
- Heart Arrest
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Lars Wiuff AndersenUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. There will be ten enrolling sites in Denmark. 492 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vasopressin and methylprednisolone | Experimental | Drug: Vasopressin, Arginine, Drug: MethylprednisoloneThe study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). |
| Placebo | Placebo comparator | Drug: NaClThe placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation
Key exclusion criteria (4 listed)
- Clearly documented "do-not-resuscitate" order prior to the cardiac arrest
- Prior enrollment in the trial
- Invasive mechanical circulatory support at the time of the cardiac arrest
- Known or suspected pregnancy at the time of the cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vasopressin, Arginine20 IE of vasopressin per dose for a maximum of four doses (80 IU) | Drug | Vasopressin and methylprednisolone |
| Methylprednisolone40 mg methylprednisolone once | Drug | Vasopressin and methylprednisolone |
| NaClPlacebo | Drug | Placebo |
Primary outcome
Number of Participants With Return of Spontaneous Circulation
Time frame: During the cardiac arrest, an average of 20 minutes
Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes
2 secondary outcomes
Number of Participants That Survived 30 Days
Time frame: At 30 days
Number of Participants With a Favorable Neurological Outcome at 30 Days
Time frame: At 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34587236Andersen LW, Isbye D, Kjaergaard J, Kristensen CM, Darling S, Zwisler ST, Fisker S, Schmidt JC, Kirkegaard H, Grejs AM, Rossau JRG, Larsen JM, Rasmussen BS, Riddersholm S, Iversen K, Schultz M, Nielsen JL, Lofgren B, Lauridsen KG, Solling C, Paelestik K, Kjaergaard AG, Due-Rasmussen D, Folke F, Charlot MG, Jepsen RMHG, Wiberg S, Donnino M, Kurth T, Hoybye M, Sindberg B, Holmberg MJ, Granfeldt A. Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Oct 26;326(16):1586-1594. doi: 10.1001/jama.2021.16628.
- Derived from this study: PubMed 34223347Andersen LW, Sindberg B, Holmberg M, Isbye D, Kjaergaard J, Zwisler ST, Darling S, Larsen JM, Rasmussen BS, Lofgren B, Lauridsen KG, Paelestik KB, Solling C, Kjaergaard AG, Due-Rasmussen D, Folke F, Charlot MG, Iversen K, Schultz M, Wiberg S, Jepsen RMHG, Kurth T, Donnino M, Kirkegaard H, Granfeldt A. Vasopressin and methylprednisolone for in-hospital cardiac arrest - Protocol for a randomized, double-blind, placebo-controlled trial. Resusc Plus. 2021 Jan 30;5:100081. doi: 10.1016/j.resplu.2021.100081. eCollection 2021 Mar.
- Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. Data will be completely anonymized according to Danish law. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. There will be no predetermined end date for the data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars W Andersen, MD, MPH, PhD, DMSc principal investigator
Aarhus University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vasopressin, Arginine, Methylprednisolone and NaCl in people with Heart Arrest, run by Lars Wiuff Andersen at 10 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Return of Spontaneous Circulation (time frame: During the cardiac arrest, an average of 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640949, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.